Healthy
Conditions
Brief summary
The clinical trial aims to assess the pharmacokinetics, safety and tolerability of HIP1502 in healthy male subjects.
Interventions
DRUGvarenicline tartrate 1mg (HGP1604, R) - varenicline oxalate 1mg (HIP1502, T), RT
varenicline tartrate 1mg (HGP1604) was used as a reference drug and varenicline oxalate 1mg (HIP1502) was used as a test drug.
DRUGvarenicline oxalate 1mg (HIP1502, T) - varenicline tartrate 1mg (HGP1604, R), TR
varenicline tartrate 1mg (HGP1604) was used as a reference drug and varenicline oxalate 1mg (HIP1502) was used as a test drug.
Sponsors
Korea University Anam Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
an open-label, randomized, single-dose crossover clinical trial
Eligibility
Sex/Gender
ALL
Age
20 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy volunteers aged between ≥20 and ≤45 years old 2. Weight ≥ 50 kg, with calculated body mass index (BMI) of ≥ 18 and ≤ 29.9 kg/m2 3. Subject who voluntarily agrees to participate in this study and signs the informed consent form.
Exclusion criteria
1. History or presence of clinically significant and active cardiovascular, respiratory, hepatobiliary, renal, hematological, oncological, urinary, psychiatric, gastrointestinal, endocrine, immune, dermatologic or neurologic disorder. 2. With symptoms indicating acute illness within 28 days prior to the first IP administration. 3. Any medical history that may affect drug absorption, distribution, metabolism, and excretion. 4. Any clinically significant activity of chronic medical illness. 5. History of any clinically significant allergic reaction including induced by varenicline (However, mild allergic rhinitis or allergic dermatitis which do not require medication could be included). 6. Positive blood tests for HBs Ag, anti-HCV Ab, anti-HIV Ab, or VDRL. 7. Use of any prescription drugs and herbal preparations within 14 days prior to study drug administration or use of over-the-counter medications (OTC) and vitamin products within 10 days prior to study drug administration. 8. Inability to take standard hospital diet. 9. Donation of blood within 60 days prior to study drug administration or apheresis within 20 days, or blood transfusion within 30 days prior to the first IP administration. 10. Exposure to any investigational drug or placebo within 90 days prior to the last IP administration. 11. Subjects with excessive caffeine intake (more than 5 cups/day), heavy or regular alcohol intake (more than 210 g/week). 12. Any use of tobacco or nicotine within three months. 13. Subjects rejected to use clinically effective contraceptive methods during the study period. 14. Subjects having been deemed inappropriate for the trial as determined by the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUC | 0 (predose) ~ 96 hours | area under the plasma concentration-time curve |
| Cmax | 0 (predose) ~ 96 hours | maximum plasma concentration of the drug |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tmax | 0 (predose) ~ 96 hours | time to maximum plasma concentration |
| T1/2 | 0 (predose) ~ 96 hours | terminal elimination half-life |
| CL/F | 0 (predose) ~ 96 hours | apparent total body clearance of the drug from plasma |
| Vd/F | 0 (predose) ~ 96 hours | apparent volume of distribution |
Countries
South Korea
Outcome results
None listed